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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036423
Receipt No. R000041502
Scientific Title semi-experimental study
Date of disclosure of the study information 2019/06/01
Last modified on 2019/04/05

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Basic information
Public title The Development of the Intravenous Drip Management System by the ICT Utilization
Acronym The Development of the Intravenous Drip Management System by the ICT Utilization
Scientific Title semi-experimental study
Scientific Title:Acronym semi-experimental study
Region
Japan

Condition
Condition Patients receiving fluid therapy
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The development and evaluation of intravenous drip management system by the ICT utilization
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference of intravenous drip doses per one hour by the presence or absence of system utilization
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Nurses manages of intravenous drip with the system mobile.
Interventions/Control_2 Nurses manages of intravenous drip without the system mobile.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients that circulation status and respiratory status are stable, and the patients who got permission of the chief physician.
Key exclusion criteria The patients that circulation status and respiratory status are unstable, and the disturbed patient by delirium and dementia.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Chiahru
Middle name
Last name Matsumoto
Organization Kumamoto University
Division name Department of Nursing, Faculty of Life Sciences
Zip code 862-0976
Address 4-24-1, Kuhonji, Chuo-ku, Kumamoto, Kumamoto 862-0976, Japan
TEL 096-373-5517
Email matsu-c@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name Chiahru
Middle name
Last name Matsumoto
Organization Kumamoto University
Division name Department of Nursing, Faculty of Life Sciences
Zip code 862-0976
Address 4-24-1, Kuhonji, Chuo-ku, Kumamoto, Kumamoto 862-0976, Japan
TEL 096-373-5517
Homepage URL
Email matsu-c@kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University
Institute
Department

Funding Source
Organization Sanritz Autmation Co, Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kumamoto University
Address 1-1-1, Honjo, Chuo-ku, Kumamoto, kumamoto 860-8556, Japan
Tel 096-373-5966
Email byi-senshin@jimu.kumamoto-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 05 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041502

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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